Cytokinetics (CYTK), Amgen (AMGN) to Advance Omecamtiv Mecarbil to Phase 3

September 1, 2016 8:32 AM EDT

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Cytokinetics, Inc. (Nasdaq: CYTK) today announced the advancement of omecamtiv mecarbil to Phase 3 clinical development with a cardiovascular outcomes clinical trial expected to initiate in the fourth quarter of 2016. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of patients with chronic heart failure.

The decision to proceed to Phase 3 development follows the review of results from prior clinical trials, including COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure. Data from COSMIC-HF were first presented in a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2015. COSMIC-HF met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. In addition, Amgen and Cytokinetics have convened meetings with regulatory authorities to inform plans for omecamtiv mecarbil in a Phase 3 clinical trials program.

"Progression of omecamtiv mecarbil to Phase 3 is a major milestone for our company as well as our collaboration with Amgen and reflects our collective commitment to the heart failure community,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased that the comprehensive clinical trials program that we have jointly conducted for omecamtiv mecarbil has contributed data that provide a compelling rationale to advance the development of our cardiac myosin activator to an international outcomes trial for the potential treatment of patients with chronic heart failure.”

The Phase 3 outcomes trial will be conducted by Amgen in collaboration with Cytokinetics. As part of the Phase 3 clinical trials program, Cytokinetics and Amgen are also planning a potential exercise performance/cardiac function clinical trial to be conducted by Cytokinetics. Cytokinetics is eligible to receive pre-commercialization and commercialization milestone payments on omecamtiv mecarbil and royalties that escalate based on increasing levels of annual net sales. Cytokinetics has the opportunity to earn increased royalties by sharing certain Phase 3 development costs. In that case, Cytokinetics could co-promote omecamtiv mecarbil in North America and would have an agreed role in commercialization activities.

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